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Recruiting NCT05494021

China Lung Cancer Screening (CLUS) Study Version 3.0

No phase Interventional Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Whole-process management software, LDCT detection.
Who it may be relevant to
Registry conditions: Lung Cancer. Basic parameters: 45 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Lung Cancer Screening With Low-dose CT in China (CLUS Study) Version 3.0

Overview

CLUS version 1.0, had proven that LDCT led to a 74.1% increase in detecting early-stage lung cancer compare to usual care (NCT02898441). CLUS version 2.0 evaluated the efficacy of new techniques (AI, AFI and MTB) in fostering the implementation of lung cancer screening (NCT03975504). The present multi-center study is performed to evaluate the effectiveness of different lung cancer screening strategy and validate our previous findings. 100,000 high-risk subjects (age 45-75) were recruited to take LDCT screening (Baseline + 2 biennial repeated LDCT screening). Follow-up for lung cancer incidence, lung cancer mortality and overall mortality was performed. Blood samples were stored in a Biobank. Management of positive screening test was carried out by a pre-specified protocol.

Interventions

  • Other Whole-process management software
    Enrolled participants will managed by a pre-designed software. The software would provide helpful assistance, such as lung cancer education, decision-making, assisting in making and attending LCS LDCT appointments, arranging follow-up when needed, tobacco cessation support for smokers, treatment assistance if diagnosed as lung cancer.
  • Device LDCT detection
    LDCT were performed in both arm. The abnormal nodules were defined as noncalcified nodules (NCN) larger than 5 mm

Primary outcome measures

  • The mortality rate of lung cancer [Time frame: 5 years]
  • The attendance rate of high-risk individuals [Time frame: 5 years]
  • The adherence rate of high-risk individuals [Time frame: 5 years]
Secondary outcome measures (3)
  • The mortality of all-cause [Time frame: 5 years]
  • The detection rate of lung nodules [Time frame: 5 years]
  • The incidence rate lung cancer [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

  • Eligible participants were those aged 45-75 years, and with either of the following risk factors:
  • history of cigarette smoking ≥ 20 pack-years, and, if former smokers, had quit within the previous 15 years;
  • malignant tumors history in immediate family members;
  • personal cancer history;
  • professional exposure to carcinogens;
  • long term exposure to second-hand smoke;
  • long term exposure to cooking oil fumes.

Exclusion criteria

  • Had a CT scan of chest within last 12 months
  • History of any cancer within 5 years

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Screening

Study locations

China · 1 center
  • Shanghai Chest hospital — Shanghai

Identifiers

NCT: NCT05494021 · CLUS 3.0

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗